Global Dental Science

GUDID D843GDS9525B10

Denture Base Material

GLOBAL DENTAL SCIENCE LLC

Dental appliance fabrication material, thermoplastic

• Primary Device ID: D843GDS9525B10
• NIH Device Record Key: 322aa65d-4f50-4fc9-a6da-bdf60145f040
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Global Dental Science
• Version Model Number: PMMA Puck
• Company DUNS: 037170061
• Company Name: GLOBAL DENTAL SCIENCE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 4802757144
• Email: customerservice@globaldentalscience.com
• Phone: 4802757144
• Email: customerservice@globaldentalscience.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D843GDS9525B10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153590

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [Global Dental Science]

• D843PCK0: Denture Base Material
• D843GDS9830LT20: Denture Base Material
• D843GDS9825OM30: Denture Base Material
• D843GDS9825LT20: Denture Base Material
• D843GDS9825B10: Denture Base Material
• D843GDS9825AVO0: Denture Base Material
• D843GDS9825A30: Denture Base Material
• D843GDS9825A20: Denture Base Material
• D843GDS9825A10: Denture Base Material
• D843GDS9820OM10: Denture Base Material
• D843GDS9820LT20: Denture Base Material
• D843GDS9820BL0: Denture Base Material
• D843GDS9820B10: Denture Base Material
• D843GDS9820A30: Denture Base Material
• D843GDS9820A20: Denture Base Material
• D843GDS9820A10: Denture Base Material
• D843GDS9525BL0: Denture Base Material
• D843GDS9525B10: Denture Base Material
• D843GDS9525A30: Denture Base Material
• D843GDS9525A20: Denture Base Material
• D843GDS9525A10: Denture Base Material
• D843GDS9520BL0: Denture Base Material
• D843GDS9520B10: Denture Base Material
• D843GDS9520A30: Denture Base Material
• D843GDS9520A20: Denture Base Material
• D843GDS9520A10: Denture Base Material